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Bioniche Pharma Chooses TrackWise for its Deviation Control Solution
Date:3/3/2008

HOLMDEL, N.J., March 3 /PRNewswire/ -- Sparta Systems, Inc. (Sparta), the maker of TrackWise,(R) and the market leader in enterprise quality and compliance management software, announced today that Bioniche Pharma, a leading developer and manufacturer of sterile injectable pharmaceutical and Medical Device products, deployed TrackWise to handle its critical quality management and compliance activities.

Given the complexity of the pharmaceutical field, companies face strict regulations that require stringent levels of accuracy. Deviations from validated and other processes can affect quality, and as a result, need to be recorded, assessed for product impact and investigated to determine root cause.

After a stringent vendor evaluation process, Bioniche Pharma selected TrackWise to replace its manual systems that manage deviations. TrackWise helps organizations increase efficiency by managing all deviations and other events in a consolidated repository - resulting in faster time-to-closure. Initial deployment of TrackWise will manage deviations, and then a phased rollout will include customer complaints, incidents, CAPA and change controls.

"The utilization of TrackWise is an excellent demonstration of the Continuous Improvement Program at Bioniche Pharma. TrackWise delivers significant benefits over manual systems, and will allow us to electronically record all quality issues in a single integrated system," said Andrew Hall, Director of Quality and Qualified Person at Bioniche Pharma.

"We are very pleased to have Bioniche Pharma join the ranks of the many innovative companies utilizing TrackWise," stated Sahaf Flam, Managing Director of Sparta Systems Europe. "TrackWise offers its customers a 100 percent configurable solution to meet their regulatory and compliance needs, and the solution can be deployed across any number of quality areas without requiring custom code or scripting to implement user requirements."

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